BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OraMem Sustained Absorbable Collagen Membrane

    Reg #: 3003418325 · FEI: 3003418325 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Integra LifeSciences Corporation
    Registration Number
    3003418325
    FEI Number
    3003418325
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1100 Campus Road
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992216

    Owner / Operator

    Firm Name
    Integra LifeSciences Corporation
    Operator Number
    9004007
    Address
    1100 Campus Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US

    Products

    Device Name Product Code
    Bone Grafting Material, Synthetic LYC

    Proprietary Names

    OraMem Sustained Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility